Translator Reviews ( Japanese → English )

Japanese

については、既にMF変更の申請手続きをしており、PMDAから2回目の問い合わせが来ております。貴社が日本市場への見直しを検討している中で、大変恐縮ですが、PMDAへの回答が必要ですので、下記の三つの項目について、ご回答を頂けないでしょうか。2と3については、弊社で行いますが、ルール上、貴社の同意が必要ですので、回答いただけると助かります。第一回の照会事項で回答されましたが１についてNIRからTLCの変更した適切性の説明がなかったので今回第二回の照会事項で再度説明の依頼があった

English

As for xx, I have already made an arrangement of application for changing FM, and PMDA has made an inquiry for the second time. I know that you are discussing reviewing to the Japanese market. I hate to ask you, but would you answer the three items listed below since I have to answer the PMDA. We will handle 2 and 3. However, as we need our agreement by rule, may I ask you to answer them? It was answered in the first reference, but as NIR has not explained appropriateness of change of TLC about 1, they asked us to explain in the second reference this time.